Breast Cancer Clinical Trial

Yoga for Aromatase Inhibitor-associated Joint Pain

Summary

The purpose of this study is to determine whether it might be practical and useful to investigate the effectiveness of yoga classes in relieving joint pain associated with the use of a class of medications known as aromatase inhibitors.

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Full Description

The study uses a single-arm design. All study participants will be assigned to an intervention condition in which they participate in group Iyengar yoga classes for 90 minutes twice per week for 12 weeks (total of 24 classes). Study outcomes are assessed: 1) following recruitment but prior to the first yoga class; and 2) within two weeks post-intervention (follow-up). Additionally, a brief assessment of pain will be conducted four weeks and eight weeks after the start of yoga classes.

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Eligibility Criteria

Inclusion Criteria:

Have been diagnosed with stage 0-III breast cancer
Have completed local and/or adjuvant breast cancer therapy (with the exception of hormonal therapy) at least one month previously
Are post-menopausal defined as defined as no menses in the past 12 months
Are currently prescribed an aromatase inhibitor (AI) medication (anastrozole, letrozole, or exemestane) by a Moffitt-affiliated physician
Report joint pain that started or worsened after initiation of AI medication
Report worst pain score > 4 in the preceding week on an 11-point (0-10) numeric rating scale

Exclusion Criteria:

Have been diagnosed with another form of cancer (except nonmelanoma skin cancer) in the last five years
Have uncontrolled cardiac disease, pulmonary disease, or infectious disease
Have physical symptoms or conditions that could make yoga unsafe (i.e., neck injuries, dizziness, shortness of breath, chest pain, or severe nausea)
Have a body mass index (BMI) > 40 kg/m^2 (based on difficulties severly obese individuals may have with engaging in Iyengar yoga poses)
Have joint pain attributed to inflammatory arthritic conditions (i.e., rheumatoid arthritis, gout, pseudo-gout) per medical record or patient history
Had surgery within the past 3 months
Had injections of medication within the last 3 months to joint(s) currently painful
Are currently using corticosteroids or opioid medications
Are currently attending yoga classes
Do not speak or read standard English
Are scheduled or are planning to discontinue AI medication in the next 16 weeks
Do not have sufficient access to the Internet to complete study assessments

Study is for people with:

Breast Cancer

Estimated Enrollment:

16

Study ID:

NCT01951976

Recruitment Status:

Completed

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

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There is 1 Location for this study

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H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

16

Study ID:

NCT01951976

Recruitment Status:

Completed

Sponsor:


H. Lee Moffitt Cancer Center and Research Institute

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